MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT TRAY SLEEVE POR M/L 53MM; MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY

Model Number	1294-54-120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The patient was revised due to end of stem pain.The surgeon revised the entire construct to a competitive company.A depuy cement was used.No surgical delay.Doi: (b)(6) 2019, dor: (b)(6) 2021, left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: MBT TRAY SLEEVE POR M/L 53MM
• Common Device Name: MBT TIBIAL TRAY : KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11462619
• Report Number: 1818910-2021-04908
• Device Sequence Number: 14351963
• Product Code: NJL
• UDI-Device Identifier: 10603295026433
• UDI-Public: 10603295026433
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1294-54-120
• Device Catalogue Number: 129454120
• Device Lot Number: J26G18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MBT REVISION CEM TIB TRAY SZ 4; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC*SIGMA DIS AUG 4MM,SZ4,LEFT; PFC*SIGMA TC3 FEM LEFT SZ4; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S4,17.5; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 75X16MM FLUTED; UNKNOWN BONE CEMENT; MBT REVISION CEM TIB TRAY SZ 4; PFC SIGMA FEM POST AUG SZ4 4MM; PFC SIGMA FEM POST AUG SZ4 4MM; PFC*SIGMA DIS AUG 4MM,SZ4,LEFT; PFC*SIGMA TC3 FEM LEFT SZ4; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S4,17.5; UNIVERSAL FEM SLV FUL POR 31MM; UNIVERSAL STEM 75X16MM FLUTED; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR